Phase I Biomarker Study (BMS-936558)

• Immunomodulatory activity as measured by the functional and phenotypic characterization of peripheral immune cells, modulation/changes in soluble factors, and the characterization of tumor immune infiltrates and the expression of tumor markers [ Time Frame: Biomarker samples will be collected prior to the first study treatment through up to 24 weeks following initiation of study treatment ] [ Designated as safety issue: No ]
  Immunomodulation across the 4 treatment arms will be evaluated to explore these measures at multiple doses
  
  

• Safety and tolerability of BMS-936558 as measured by the incidence and severity of adverse events [ Time Frame: Assessed at a minimum of every 3 weeks up to 70 days following discontinuation of study drug (at progression of disease, toxicities requiring discontinuation, withdrawal of consent or study closure) ] [ Designated as safety issue: Yes ]
  
• Progression free survival in the BMS-936558 arms [ Time Frame: Progression free survival will be assessed in each individual treatment arm by tumor assessments every 6 weeks ] [ Designated as safety issue: No ]
  
• The tumor response rate in the BMS-936558 arms as assessed by the Investigator assessment of best overall response [ Time Frame: Up to 22 months after study start ] [ Designated as safety issue: No ]
  The tumor response rate will be assessed on all subjects at the time they discontinue study treatment by the Investigators assessment of best overall response for a subject
  
  
• Overall response rate for BMS-936558 as assessed by the number of subjects which demonstrate an objective response divided by the total number of treated subjects with measurable disease at baseline [ Time Frame: response rate will be assessed by tumor assessments every 6 weeks ] [ Designated as safety issue: No ]
  
• Disease control rate for BMS-936558 as measured by the number of subjects with an objective response + the number of subjects with stable disease divided by the total number of treated subjects with measurable disease at baseline [ Time Frame: disease control will be assessed by tumor assessments every 6 weeks ] [ Designated as safety issue: No ]
  
• Duration of objective response for BMS-936558 as measured by the time when the criteria for an objective response are first met until the date of documented disease progression or death [ Time Frame: Duration of response will be assessed by tumor assessments every 6 weeks ] [ Designated as safety issue: No ]
  
• Duration of stable disease for BMS-936558 as measured in subjects whose best overall response is stable disease as the time from baseline until the date of documented disease progression or death [ Time Frame: Duration of response will be assessed by tumor assessments every 6 weeks ] [ Designated as safety issue: No ]
  
• Immunogenicity of BMS-936558 as measured by the detection of human antibodies against BMS-936558 [ Time Frame: Serum sample collected at baseline, 12 weeks following initiation of study treatment; and during the first 2 follow-up visits in the follow-up phase ] [ Designated as safety issue: Yes ]
  

Intervention Model: Parallel Dose Comparison